Search results for " traceability"
Article
Traceability in Western Blot Imaging: Considerations for GxP
In regulated environments, electronic record-keeping can improve both traceability and efficiency – but compliance with regulations like Code of Federal Regulations Part 11 and European Union GMP Anne…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
He notes that several manufacturers, including Fresenius Kabi, opted to go beyond basic traceability requirements. The company decided to serialize its Diprovan anesthetic, a workhorse generic product…
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New Therapies Present Scaling Challenges
The entire manufacturing chain, from patient back to patient, must retain sterility and traceability. Thus, autologous cell therapies require a decentralized scaled-out manufacturing process—to produc…
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Using Software in Process Validation
There needs to be integrated support for documentation with 100% clarity and traceability. In addition to this, version control of all software systems used within the pharmaceutical manufacturing pro…
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Automating the Biomanufacturing Process
Ensuring traceability is key, he emphasizes. For example, if an equipment component that is used in production is later suspected of having contributed to quality problems with one specific batch, aut…
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Automating Bioprocesses
Maintaining data integrity and traceability becomes more complex.
Another difference is in the sensors used to collect data and control the process. SUS employ either disposable or non-product con…
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Drug Quality Key to Innovation and Access
A broad industry group adopted guidelines on using the Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability of pharmaceuticals (3). Achieving stand…
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Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
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Digitalization: The Route to Biopharma 4.0
It helps to increase transparency and traceability in the process chain, automates data acquisition and management, and improves visibility in the platform. Adhering to regulatory compliances is criti…
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
cell culture
In this video, Andreas Castan, Strategic Technology Partnerships Leader at Cytiva, discusses the current techniques and challenges in scaling between bioreactors.
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